Ignite Creation Date:
2024-05-06 @ 8:07 PM
Last Modification Date:
2024-10-26 @ 3:21 PM
Study NCT ID:
NCT06266988
Status:
NOT_YET_RECRUITING
Last Update Posted:
2024-02-20
First Post:
2024-01-25
Brief Title:
A Bioequivalence Study of SacubitrilValsartan Film-coated Tablets Under Fasting Conditions
Sponsor:
Viatris Inc
Organization:
Viatris Inc
Study Overview
Official Title:
A Bioequivalence Study of Two Formulations of SacubitrilValsartan 97 mg103 mg Film-coated Tablets in Healthy Thai Subjects Under Fasting Conditions
Status:
NOT_YET_RECRUITING
Status Verified Date:
2024-02
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
Brief Summary:
Primary objective is to is to evaluate the bioequivalence of two formulations
Detailed Description:
The objectives of this study is to evaluate the bioequivalence of two formulations of sacubitrilvalsartan 97 mg103 mg film coated tablets Entresto Reference and Sacubitril and Valsartan Tablets 97mg103mg Test after a single oral dose administration in healthy Thai subjects under fasting conditions and secondarily to examine the pharmacokinetics and safety of sacubitril sacubitrilat and valsartan in healthy Thai subjects under fasting conditions
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
False
Is a FDA Regulated Device?:
False
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None